The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1051–1075 of 3531

  • ModerateFDA (Devices)·Z-0658-2024·2024-01-17

    Medical Device Recall: Baxter Ostene Hemostasis Material Marketing Brochure Inaccuracy

    Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0686-2024·2024-01-17

    FDA updates cleaning instructions for EVIS EXERA III bronchovideoscope

    Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. BF-P190, EVIS EXERA III Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24082·2024-01-11

    Justin Boots Keaven WP Met Guard Work Boots Recalled Due to Missing Metatarsal Guard

    Boot Royalty is recalling about 3,200 Justin Boots Keaven WP Met Guard Work Boots (Model SE4570) because the metatarsal guard may be missing, creating a crush hazard to the wearer's feet. One injury has been reported.

    Product
    Justin Boots Keaven WP Met Guard Work Boots Model SE4570
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0625-2024·2024-01-10

    Reverse Shoulder Joint Implant System Recalled for Mislabeling

    Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.

    Product
    Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0626-2024·2024-01-10

    Patella implant component recalled due to labeling error

    Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.

    Product
    REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2024·2024-01-10

    Impella Connect medical device software portal disables unevaluated features

    Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.

    Product
    Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0216-2024·2024-01-10

    OTC Nasal Decongestant Recalled Due to Manufacturing Process Deviation

    Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.

    Product
    OXYMETAZOLINE HYDROCHLORIDE — OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0214-2024·2024-01-10

    Oxymetazoline Nasal Spray Recalled Due to Manufacturing Process Deviation

    Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.

    Product
    OXYMETAZOLINE HYDROCHLORIDE — OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0217-2024·2024-01-10

    Nasal Decongestant Recalled for Possible Manufacturing Water Contamination

    Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.

    Product
    OXYMETAZOLINE HYDROCHLORIDE — OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0213-2024·2024-01-10

    Prescription Oral Solution Eprontia Recalled for Out-of-Specification Impurity

    Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.

    Product
    EPRONTIA — EPRONTIA (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2024·2024-01-10

    KeySplint Hard Clear dental devices recalled for incorrect instructions

    Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.

    Product
    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2024·2024-01-10

    Serology ToRCH positive control specimen recalled for decreased HSV reactivity

    Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.

    Product
    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0215-2024·2024-01-10

    OTC Cough Medicine Recalled for Potential Water Contamination Risk

    Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.

    Product
    Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
    Category
    Drug
    Distribution
    2 states
  • ModerateNHTSA·24V575000·2024-01-08

    2024 Chevrolet Malibu Vehicles Recalled for Wrong Owner Manual

    General Motors is recalling 2024 Chevrolet Malibu vehicles that may have an incorrect owner's manual. The wrong manual could contain inaccurate vehicle safety information.

    Product
    CHEVROLET — 2024 CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0186-2024·2024-01-03

    Leader Nasal Decongestant PE recalled due to improper storage conditions

    Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.

    Product
    Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2024·2024-01-03

    Chlorthalidone Tablets Recalled for Temperature Storage Deviations

    Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0195-2024·2024-01-03

    OTC Throat Lozenges Recalled for Temperature Storage Deviation

    Ricola Cherry Honey Herb Throat Drops are recalled because products in batch 2000058693 were exposed to temperatures outside the labeled storage conditions during distribution. The Class II recall affects nationwide shipments.

    Product
    NATURAL CHERRY HONEY HERB THROAT DROPS — NATURAL CHERRY HONEY HERB THROAT DROPS (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0198-2024·2024-01-03

    Terconazole Vaginal Suppositories Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling Terconazole Vaginal Suppositories (batch 1014228A) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.

    Product
    TERCONAZOLE — TERCONAZOLE (TERCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0187-2024·2024-01-03

    Birth control tablets recalled nationwide for temperature storage deviation

    Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.

    Product
    Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0656-2024·2024-01-03

    Rong Shing Dried Peach recalled for undeclared cyclamate sweetener

    Rong Shing Dried Peach (6 oz) is recalled because it contains undeclared cyclamate, an artificial sweetener not approved for use in the United States. The product was distributed in New York and Texas.

    Product
    'Rong Shing' Dried Peach; 6 oz; packaged in a clear plastic bottle; store at room temperature; UPC 6950296800195
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0174-2024·2024-01-03

    Colgate Total SF Toothpaste recalled for improper storage temperature exposure

    Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.

    Product
    Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0175-2024·2024-01-03

    Dicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions

    Cardinal Healthcare is recalling Dicyclomine Hydrochloride 20 mg tablets due to temperature exposure outside labeled storage conditions. No illnesses have been reported.

    Product
    DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0183-2024·2024-01-03

    Folic Acid tablets recalled for improper storage conditions

    Cardinal Healthcare recalls Folic Acid tablets (1mg, batch H08221) nationwide due to storage temperature deviations during manufacturing. No illnesses reported.

    Product
    FOLIC ACID — FOLIC ACID (FOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide